Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Managed Services
Validation Expert
-Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
-Lead and coordinate validation and re-validation efforts, maintaining audit-ready lifecycle documentation.
-Support change management, upgrades, migrations, and decommissioning while preserving validation state.
-Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
-Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
-Standardize and reuse validation templates, protocols, and procedures across systems and clients.
-Monitor regulatory developments and adapt validation strategies accordingly.
-Integrate validation with service processes such as incident management, CAPA, and change control.
-Operate within delivery methodologies like ITIL, Agile, DevOps, and Waterfall.
-Candidates must be willing and able to work according to Central European Time (CET) business hours
1
-Bachelor’s degree in Computer Science, Engineering, or Life Sciences; Master’s preferred
-5+ years of experience in computer system validation, IT compliance, or quality assurance
-Strong knowledge of FDA regulations (21 CFR Part 11, 820), GAMP5, and QMS in pharma/MedTech
-Experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN
-Familiarity with ITIL-based service operations and testing automation tools
-Strong documentation, communication, and stakeholder collaboration skills
-Motivation to improve global healthcare and deliver exceptional service
-Willingness to travel up to 20% and flexibility in working hours based on project needs
2604
Kosice, Malaysia
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Managed Services
-Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
-Lead and coordinate validation and re-validation efforts, maintaining audit-ready lifecycle documentation.
-Support change management, upgrades, migrations, and decommissioning while preserving validation state.
-Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
-Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
-Standardize and reuse validation templates, protocols, and procedures across systems and clients.
-Monitor regulatory developments and adapt validation strategies accordingly.
-Integrate validation with service processes such as incident management, CAPA, and change control.
-Operate within delivery methodologies like ITIL, Agile, DevOps, and Waterfall.
-Candidates must be willing and able to work according to Central European Time (CET) business hours
1
-Bachelor’s degree in Computer Science, Engineering, or Life Sciences; Master’s preferred
-5+ years of experience in computer system validation, IT compliance, or quality assurance
-Strong knowledge of FDA regulations (21 CFR Part 11, 820), GAMP5, and QMS in pharma/MedTech
-Experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN
-Familiarity with ITIL-based service operations and testing automation tools
-Strong documentation, communication, and stakeholder collaboration skills
-Motivation to improve global healthcare and deliver exceptional service
-Willingness to travel up to 20% and flexibility in working hours based on project needs
2604
Kosice, Malaysia